A randomised Phase II trial of Imatinib (IM) versus Hydroxychloroquine (HCQ) and IM for patients with Chronic Myeloid Leukaemia (CML) in Cytogenetic Response (CyR) with residual disease detectable by quantitative polymer chain reaction (Q-PCR)

HS Greater Glasgow and Clyde (UK)0 个研究点目标入组 66 人开始时间: 2009年11月19日最近更新: 2019年6月17日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 66

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

性别: All

入选标准

•1. Male or female patients aged =18 years old
•2. Ability to provide written informed consent prior to participation in the study and any related procedures being performed
•3. CML Chronic phase (CP) patients who have been treated with and tolerated imatinib for 1-3 years, have achieved at least MCyR and continue to be BCR/ABL+ by quantitative polymerase chain reaction (Q-PCR). Patients should be receiving a stable dose of imatinib for 6 months prior to study entry.
•4. Patients must meet the following laboratory criteria:
•4.1. Absolute neutrophil count (ANC) and platelet (PLT) need to be stable and in the normal range for =2 months
•4.2. Serum albumin >3 g/dl
•4.3. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =2.5 x upper limit of normal (ULN)
•4.4. Serum bilirubin =1.5 x ULN
•4.5. Serum creatinine =1.5 x ULN or 24-hour creatinine clearance >=50 ml/min
•4.6. Serum potassium = Lower limit of normal (LLN)
•5. Eastern Cooperative Oncology Group (ECOG) Performance Status of =2

排除标准

•1. Patient who have been treated with imatinib <1 or >3 years or patients who have changed dose in previous 6 months
•2. Impaired cardiac function including any one of the following:
•2.1. Screening electrocardiogram with a QTc >450 msec
•2.2. Patients with congenital long QT syndrome
•2.3. History or presence of sustained ventricular tachycardia
•2.4. Any history of ventricular fibrillation or torsades de pointes
•2.5. Congestive heart failure (New York Heart Association class III or IV)
•2.6. Uncontrolled hypertension
•3. Patients with severe gastrointestinal (GI) disorder, uncontrolled epilepsy, known G6PD deficiency, known porphyria, moderate or severe psoriasis, known myaesthenia gravis or other concurrent severe and/or uncontrolled medical conditions
•4. Patients who have received chemotherapy, any investigational drug or undergone major surgery <4 weeks prior to starting study drug or who have not recovered from side effects of such therapy
•5. Concomitant use of any other anti-cancer therapy or radiation therapy
•6. Female patients who are pregnant or breast feeding or patients of reproductive potential not willing to use a double method of contraception including a barrier method (i.e. condom) during the study and 3 months after the end of treatment
•7. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days of the first administration of oral HCQ
•8. Male patients whose sexual partners are WOCBP not willing to use a double method of contraception including condom during the study and 3 months after the end of treatment
•9. Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent

研究者

发起方

HS Greater Glasgow and Clyde (UK)

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